Sr QA Specialist
2 months ago
Sr QA Specialist I (Operations)
Location: El Segundo CA NA245
NA%Onsite
Senior Specialist of Quality Operationsresponsible for Product Disposition. This position will participatein Quality activities to ensure compliance with applicable qualityobjectives and regulatory requirements. This position is located atour El Segundo CA site and report into the Associate Director ofQuality Operations.
NOTE: Position is DayShift including weekends and requires onsite presence.
Responsibilities
Perform Product Dispositionand Lot Closure. Includes commercial and clinicalproducts.
Review batchrelated documentation and ensureresolution of issues to release product
Reviewbatchrelated shipment documentation to ensure product shipmentremained in control
Provide QA oversight and review ofdeviations tied to lots. Ensure deviations are properly initiatedinvestigated and resolved in accordance with establisheddisposition timelines.
Provide QA oversight and(limited) approval of CAPAs. Ensures that associated CAPAs areinitiated and resolved.
Provide QA oversight andapproval of change records. Ensures that change records areinitiated and resolved.
Support and participate ininvestigations including batch record review.
Ensureprocess control measures are in place and followed in productmanufacturing
Maintain metrics related to productdisposition in support of the Management Review
Generateand update procedures forms and other documents
Asassigned manage and provide QA oversight for other processesincluding training warehouse/inventory redose new productintroductions etc.
Generate and report data formanagement
Maintain production (finite) disposition andteam schedules
Represent Disposition or QA Ops at plantand multisite scheduling meetings
Provide QArepresentation on projects and at team meetings
ProvideQA representation at multisite disposition meetings
Support and participate in inspections and audits
Basic Qualifications
Masters Degree and 5years of experience in GMP environment OR
BachelorsDegree and 7 years of experience in GMP environment OR
High School Degree and 11 years of experience in GMPenvironment
PreferredQualifications
Bachelors degree in the biologicalsciences or related field and minimum of 7 years progressiveexperience in a pharmaceutical biotech or biologics operation orequivalent education/work experience.
Working knowledgeand ability to apply GMPs in conformance to U.S. and EUstandards
Ability to interpret and apply procedural andregulatory guidance in potentially ambiguous situations
Ability to understand risk and provide phaseappropriate appropriatedecisions
Ability to effectively negotiate and buildcollaboration amongst individuals
Good interpersonalskills
Strong written communication skills
Strong analytical skills
Comfortable in a fastpacedsmall company environment and operate with minimaldirection
Ability to adjust workload based upon rapidlychanging priorities
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